Isolation Gown
FDA 510(k) K960999 · Copioumed Intl., Inc.
510(k) numberK960999
Submission
- Device name
- Isolation Gown
- Applicant
- Copioumed Intl., Inc.
Taipei, Taaaaiwan R.O.C., TW - Received
- March 12, 1996
- Decision date
- December 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FYC – Gown, Isolation, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3…FYC · Abbreviated | Owens & Minor (O&M) Halyard, Inc. | 05/16/2024SE |
| K230135 | Copioumed Chemotherapy Isolation GownFYC · Traditional | Copioumed International, Inc. | 10/04/2023SE |
| K223467 | Disposable Isolation GownFYC · Traditional | Nanning Tecbod Biological Technology Co., Ltd. | 02/10/2023SE |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)FYC · Traditional | Xiamen Probtain Medical Technology Co., Ltd. | 02/08/2023SE |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)FYC · Traditional | Xiamen Probtain Medical Techology Co., Ltd. | 01/04/2023SE |
| K212717 | Paneffort AAMI Level 3 Isolation GownFYC · Traditional | Paneffort, LLC | 11/30/2022SE |
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…FYC · Traditional | Medtecs (Taiwan) Corp. | 10/21/2022SE |
| K214116 | AAMI4 Isolation GownFYC · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 10/11/2022SE |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))FYC · Traditional | Allmed Medical (Hubei) Protective Products Co.… | 08/12/2022SE |
| K220528 | Surgical Isolation Cover GownFYC · Traditional | Wuhan Dymex Healthcare Co., Ltd. | 06/10/2022SE |
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| 510(k) | Device | Decision |
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| K021961 | Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteLYZ · Traditional | 07/02/2002SE |
| K021743 | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves, Color: YellowLZA · Traditional | 06/10/2002SE |
| K972624 | Poly (Vinyl) Exam Glove, Powder-FreeLYZ · Traditional | 11/06/1997SE |
| K971316 | Poly (Vinyl) Exam Glove, PowderedLYZ · Traditional | 08/27/1997SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | 08/27/1997SE |
| K961342 | Shoe Cover, Non-SterileFXP · Traditional | 12/30/1996SE |
Questions and answers
When was Isolation Gown cleared by the FDA?
Isolation Gown (K960999) received a 510(k) decision of Substantially Equivalent on December 30, 1996, 293 days after the submission was received.
What is the product code of K960999?
The FDA product code is FYC – Gown, Isolation, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.